Breathing Circuit Kits Recalled Due to Assembly Error Affecting Pressure
Percussionaire Corporation is recalling High Frequency Transport Phasitron Breathing Circuit Kits due to assembly errors that can affect pressure output. The defect could impact respiratory support to patients using this device.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4. While no deaths or serious injuries have been reported, the assembly error affecting breathing circuit pressure output poses inherent risks to patients dependent on this respiratory support device.
Plain-English summary
Percussionaire Corporation is recalling the High Frequency Transport Phasitron Breathing Circuit Kit (REF: A50605-D) due to an assembly error within the breathing circuit. The manufacturing defect can affect the pressure output delivered by the device, potentially creating a severe impact to patients.
The recall affects 2,145 units distributed across 21 U.S. states: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, Tennessee, Texas, Utah, and Virginia. The affected lot numbers are: WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930, and WO06028.
The recalled product
- Product
- High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
- Manufacturer
- Percussionaire Corporation
- Affected units
- 2,145
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- UDI: (01)10849436000331/Lot # WO05216
- WO05254
- WO05321
- WO05392
- WO05559
- WO05588
- WO05684
- WO05749
- WO05896
- WO05930
- WO06028
Distribution
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